MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 ASPIRATION CATHETER

Catalog Number CAT8XTORQ115

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.

Event Description

The patient was undergoing a thrombectomy procedure in the pulmonary artery using an indigo system aspiration catheter 8 (cat8).During the procedure, the physician placed a non-penumbra sheath in the patient's body, then advanced a cat8 through the sheath.While moving an indigo system separator 8 (sep8) in the cat8 mid procedure, it was noticed that the hub of a cat8 was separated from the rest of the catheter; therefore, the cat8 was removed.It was reported it was tight when removing the cat8 from the sheath.The procedure was completed using a new cat8, the same sheath and sep8.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CAT 8 ASPIRATION CATHETER
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7397984
• MDR Text Key: 104540890
• Report Number: 3005168196-2018-00698
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016290
• UDI-Public: 00814548016290
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/04/2020
• Device Catalogue Number: CAT8XTORQ115
• Device Lot Number: F75417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR